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Site Wise Randomization benefits and managing with IRT

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Clinical trials are essential for evidence-based medicine, providing critical insights into the efficacy and safety of new treatments. One crucial aspect of conducting clinical trials is the rando…
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Regulatory Impact Assessment; How are you handling this currently?

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Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which ar…
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Small/Mid-Size Firms: Take Low-tech, Low-cost Path for tech/software for your process

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Too often, small and mid-size companies are intimidated by the costs, complexity, and long implementations… It’s possible to turn RA/QA into a smart function much faster and cheaper than most…
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FDA: Software Assurance guidance for Production and Quality System Software

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This draft guidance is intended to: Computer Software Assurance is a risk-based approach to establish confidence in the automation used for production or quality systems, that software is fit …
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Language requirements for Manufacturers – Europe

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Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to establish national language requirements for makers of device companion materials. …
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